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A test that evaluates the likelihood of breast cancer relapse recently became the first test of genetic activity to be approved by the FDA. The test, called Mammaprint, examines the activity of 70 specific genes in a breast tumor after it has been surgically removed and then uses an algorithm to determine the risk of cancer recurrence.

The test divides women into high-risk or low-risk categories for developing cancer anywhere in the body. FDA officials told the Feb. 7 New York Times that 23% of women identified by the test as high risk had a cancer recurrence within five years, compared with 5% for the low-risk group. The test is useful, although not totally accurate, in predicting time to distant metastasis in women with Stage I or II cancer that has not spread to the lymph nodes, the FDA said.

The test results can be used to determine on an individual basis whether a woman should undergo chemotherapy, experts told the New York Times. The test is manufactured by Amsterdam-based Agendia and is already available in the Netherlands and some other countries.

Other breast cancer recurrence tests are on the U.S. market, but Mammaprint is the first to go through the FDA approval process. Home-brew tests, which are performed in a single lab (as opposed to test kits, used in hospitals and offices), do not currently require FDA approval, although the agency has indicated it may begin to regulate complex home-brew tests soon.

The state of Texas has become the latest battleground in the national debate over whether vaccination against human papillomavirus (HPV) should be mandatory. On Feb. 2, Gov. Rick Perry signed an order requiring the Texas Health and Human Services Commission to order HPV vaccination of all girls entering sixth grade.

Since the order was signed, opposition and threats of an override from Republicans in the Texas state legislature have surfaced, the Feb. 7 Washington Post reported. The governor’s requirement allows for parents to opt out of vaccination for religious or philosophical reasons but some lawmakers have advocated an opt-in system instead.

Texas is the first state to officially mandate vaccination, but at least 20 states and the District of Columbia have drafted or pending legislation on the issue. Women in Government, a national advocacy group of female state legislators, has been active in promoting the legislation across the country. Some concerns have been raised about the financial support the group’s efforts have received from Merck & Co., which manufactures Gardasil, the only HPV vaccine currently on the market.

Many physicians do not feel obligated to tell patients about or offer referrals for some legal but morally controversial medical procedures, a new study found. Researchers surveyed physicians on three issues: terminal sedation of dying patients, abortion for failed contraception and birth control for adolescents without parental approval.

Surveying a cross-sectional random sample of 2000 physicians of all specialties, the researchers found that 8% of physicians felt they had no obligation to present all possible options to patients and 6% were undecided. Asked if they have to refer patients for medical procedures to which they object on moral grounds, 18% said no. Physicians who were male or religious were most likely to believe in telling patients about their objections and least likely to feel the need to present all options or offer a referral.

Of the total survey respondents, 17% objected to terminal sedation, 42% objected to birth control for teens without parental consent and 52% objected to abortion for failed contraception. The study was published in the Feb. 8 New England Journal of Medicine.

The findings suggest that patients who want information about and access to controversial procedures may need to be proactive to determine whether their physicians will accommodate such requests, said the study's authors. They also suggested that future studies use vignettes, patient reports or direct observation to directly measure the ways in which physicians respond to moral conflict in clinical encounters. In the meantime, physicians and patients should anticipate areas of moral disagreement and negotiate accommodations before crises develop, the authors said.

Clinical news

A recent trial found that surgery plus perioperative chemotherapy was more effective than surgery alone in patients with resectable gastroesophageal adenocarcinoma.

In the randomized controlled trial, researchers studied 503 patients with adenocarcinoma of the stomach, lower esophagus or gastroesophageal junction that penetrated the submucosa, but had no evidence of distant metastases or inoperable local disease. Half of the patients were given perioperative chemotherapy with epirubicin, cisplatin, and fluorouracil for three cycles before and after surgery, while the other half received surgery alone.

Overall survival was longer in the perioperative chemotherapy group than the surgery group (five-year survival of 36% vs. 23%, number needed to treat = 8). Preoperative chemotherapy also resulted in resected tumors that were smaller and less extensive, but it did not affect the rates of postoperative complications or mortality within 30 days. The study is abstracted in the January/February ACP Journal Club.

While correct surgical treatment for patients with resectable tumors remains controversial, the results of this trial support increasing evidence that preoperative chemotherapy and radiation may be equally effective and better tolerated than therapy delivered postoperatively, said Journal Club reviewer James L. Abbruzzese, FACP, of the University of Texas and MD Anderson Cancer Center.

However, he noted that only 55% of patients treated preoperatively began postoperative chemotherapy and only 42% of patients assigned to chemotherapy completed the whole protocol, leading to questions of whether postoperative chemotherapy is necessary. In any case, the data points to the need to develop more effective, less toxic therapies, Dr. Abbruzzese noted.

Aprotinin (Trasylol) may raise the risk of death in the five years after it has been used during coronary artery bypass graft surgery, a new study found.

The 10-year study, published in the Feb. 7 Journal of the American Medical Association, examined long-term mortality in patients who, during CABG surgery, were given either aminocaproic acid, tranexamic acid, aprotinin or no antibleeding agent. Following index hospitalization, survival was assessed at six weeks, six months and annually for five years after CABG surgery among 3,876 patients in the 62-center international cohort study. The research was funded by the Ischemia Research and Education Foundation.

During five years, 20.8% of aprotinin-treatment patients died compared with 12.7% of control patients, 15.8% of aminocaproic acid patients and 14.7% of tranexamic acid patients. Covariate-adjusted survival analyses showed significant association with death for aprotinin but not the other two drugs. Multivariable logistic regression also indicated aprotinin was an independent predictor of mortality.

Study authors recommended avoiding the use of aprotinin during heart surgery “given that safer alternatives-- aminocaproic acid or tranexamic acid--are available.” Three of the study’s authors participated in a 2006 study, also published in the New England Journal of Medicine, that found that aprotinin could increase the risk of heart attack, kidney failure and stroke.

An accompanying editorial noted that while the study is important for generating new long-term data about aprotinin use, it is limited by site selection biases. The registry is a sampling of patients based on each site's anticipated annual surgical volume rather than a comprehensive database, the editorial said, and it is skewed toward low-volume cardiac centers. In addition, the mechanism for the difference in mortality rates isn’t clear, the editorial noted, and causality can’t be inferred.

As the cycle for testing new drugs and devices shortens, said the editorial, late outcomes and safety data will continue to emerge long after the efficacy trials. As a result, more comprehensive and cross-therapy studies are needed.

Aprotinin was used by 600,000 patients worldwide in 2005. Bayer, maker of the drug, said the current study findings were unreliable because aprotinin tends to be used in more complex operations, and the analysis didn’t fully account for this, the Feb. 7 New York Times said.

The Journal of the American Medical Association article and editorial are online.

FDA news

The FDA last week approved over-the-counter sales of the diet pill orlistat, which has been available by prescription since 1999.

Orlistat decreases intestinal absorption of fat, and blocks about 25% of fat consumed. It is expected to be available this summer for $1-$2 per daily dose, according to the Feb. 8 New York Times, and can be taken up to three times a day with a fat-containing meal. Orlistat’s most common side effect is loose stools, though this effect is less likely to occur in those who eat a low fat diet, the FDA said.

The FDA stressed that organ transplant recipients should not take orlistat because of possible drug interactions, and people on blood thinning medicines, or those being treated for diabetes or thyroid disease, should consult a doctor. The drug is also not recommended for people who have problems absorbing food or who aren’t overweight.

In studies, about half of those who took the drug in combination with an exercise and diet plan lost 5% of their body weight in six months, the New York Times reported. About half of patients in trials experienced gastrointestinal side effects, said the Feb. 7 Washington Post.

Orlistat, which will be manufactured in 60 mg capsules (the prescription version is 120 mg) by GlaxoSmithKline under the name “Alli,” is meant to be taken by adults 18 years and older in conjunction with a low-fat, reduced-calorie diet and exercise program. Capsules will be packaged with several reference guides on healthy eating and access to an individualized online action plan. Orlistat can reduce absorption of some nutrients, so users are urged to take a multivitamin at bedtime.

CDC news

Unintentional poisoning death rates rose 62.5% between 1999 and 2004, with most of the increase due to overdoses of legal and illegal drugs, the CDC said last week.

Death rates from drugs increased 69% over the five-year period, while death rates for substances like alcohol and solvents increased 1.3%. Poisoning increases were greatest for people in the Southern U.S.--where rates rose 114%-- closely followed by people age 15-24 (113% increase); women (103% increase); and whites (76% increase). Rural states saw the steepest climbs, with 14 of the 17 most rural states in the U.S. more than doubling their rates in five years.

Unintentional poisoning deaths include overdoses of illegal drugs and legal drugs taken for non-medical reasons, poisoning from legal drugs taken in error or at the wrong dose, and poisoning from other substances like pesticides and alcohol. Adverse effects of legal drugs taken in the proper doses aren’t included.

The largest increases in drug deaths were in the "other and unspecified," psychotherapeutic and narcotic drug categories. The results suggest that more aggressive regulatory, educational, and treatment measures are necessary to address the increase in fatal drug overdoses, the CDC said.

The CDC analyzed data from the National Vital Statistics System to obtain its results. Previous reports have also shown a substantial increase in unintentional poisoning deaths during the 1980s and 1990s.

College news

President Bush's proposed budget for fiscal year 2008, released Feb. 5, will accelerate the collapse of primary care, create access problems and pose obstacles to fundamental reform of physician payment policies. Specifically, said ACP officials, the President's proposal does not include funds to offset a pending cut in Medicare payments to physicians.

The administration’s budget seeks to squeeze some $101.5 billion of savings from Medicare and Medicaid over the next five years. The two plans cover more than one in four Americans.

A Medicare payment cut will cause severe access problems and will stand in the way of achieving long-standing and fundamental reforms in physician payment policy to support quality improvement and patient-centered primary and principal care, said ACP President Lynne M. Kirk, FACP. She emphasized that it is essential that lawmakers agree on a longer-term fix that will provide positive and stable updates, create sustained incentives for quality improvement and support patient-centered care coordinated by a personal physician.

The budget also includes reductions to the State Children’s Health Insurance Program and the Department of Veteran’s Affairs medical budget. Congress should review the President’s budget requests and assure adequate funding for programs that are critical to the health care of low-income children and adults, the elderly and veterans, said Dr. Kirk. She also called for Congress to move forward on comprehensive reforms to expand health insurance to the nearly 47 million Americans who now lack coverage.

The College is looking for a volunteer candidate to serve as a commissioner on the Accreditation Review Commission on Education for the Physician Assistant (ARC-PA). Commissioners of the ARC-PA help to support and advance physician assistant education.

Specifically, commissioners serve in work groups, are responsible for reviewing two to seven training program files, and participate in the overall discussion and decision-making relating to the accreditation of training programs. Additionally, commissioners are expected to make at least one program site visit and attend two regular meetings annually.

The three-year term begins Jan. 1, 2008. Interested applicants must be members of ACP and should be involved in the education of physician assistant trainees. Those who would like to be considered for the position should email their curriculum vitae to Patrick Alguire, FACP, Director of Education and Career Development, at palguire@acponline.org or mail to:

Patrick Alguire, FACP
Director of Education and Career Development
American College of Physicians
190 North Independence Mall West
Philadelphia, PA 19106-1572

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A 66-year-old man is evaluated for a persistent rash for 6 years' duration. The rash waxes and wanes in severity, and it becomes pruritic only after he becomes hot and sweating, such as when he mows the lawn or exercises. It has always been limited to his back and lower chest. He has never treated it. The patient is otherwise well, has no other medical problems, and takes no medication. Following a physical exam, what is the most likely diagnosis?

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